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BioAustin | Texas Medical Device Alliance | Austin Health Tech

July 2019 NEWSLETTER

CONTENTS

LIFE SCIENCE INDUSTRY NEWS 2 U.S. News: In Our Neck of the Woods… European & World News: Across the Pond… Women in Life Science & Women’s Health INDUSTRY RESOURCES & FUNDING OPPORTUNITIES 4 SPOTLIGHT: MEDTOMARKET 5

UPCOMING EVENTS 6 CAREER CORNER 8-10 TEXAS LIFE SCIENCE ORGANIZATIONS 12 VOLUNTEER OPPORTUNITIES 13 Join the BioAustin/TMDA/AHT Newsletter Team!

It’s officially summer! Find the latest, news, resources, and events from the community.

JULY 18 Austin, TX | The importance of selecting the right Board and Advisors (TMDA Quarterly Meeting) 2-4pm at the Norris Conference Center.

Get Your Ticket.

As always, if you have news, job postings, or other resources to share, please reach out to Elisa Maldonado-Holmertz ([email protected])

BioAustin | Texas Medical Device Alliance | Austin Health Tech NEWSLETTER • JULY 2019

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LIFE SCIENCE INDUSTRY NEWS In Our Neck Of The Woods…

Capital City Innovation May Network News Find a roundup of local ATX news around health innovation in the Capital City Innovation’s May recap blog post. Via Capital City Innovation. New MassChallenge Cohort Announced MassChallenge Texas announced their second Austin-based cohort. The 74 startups range in discipline from high tech to medical devices to consumer-packaged goods and from sustainable energy to agriculture. Via MassChallenge. Medical Device Safety Data From FDA Available The FDA has followed through with plans to formally end its Alternative Summary Reporting program, making 20 years’ worth of medical device safety data publicly available. Via Fierce BioTech Code of Ethics Revised AdvaMed recently revised its Code of Ethics on Interactions with U.S. Health Care Professionals (the “Code”). The revised Code is effective January 1, 2020, at which time it will supersede and replace the existing Code (effective since July 1, 2009). The Code is designed to help mitigate the inherent risk medical technology manufacturers face when they interact with HCPs. Via Gardner Law Planning To Sell A Medical Device? Read This. Medical device companies selling or planning to sell into the US market should be familiar with FDA's 21 CFR Part 820 Quality System Regulation (QSR). See 8 common mistakes to avoid via Greenlight Guru. And have you ever been tasked with sifting through medical device safety and performance requirements to create a product requirements document? Get 10 essential tips via Greenlight Guru. Across The Pond…Why are so many health-tech companies conducting research in India? Alphabet researchers just published results from a study, conducted in two Indian eye centers, evaluating an AI system designed to identify conditions that can cause blindness in people with diabetes. Microsoft has a partnership with an Indian hospital chain that used patient data and Microsoft’s machine learning capabilities to generate a model meant to assess heart attack risk. Startups see opportunity in India, too. Boston-based Sonde Health, which is trying to use voice data to develop a depression screening tool, is running a study that’s recorded the voices of 10,000 patient volunteers in Indian hospitals. And Israel-based Zebra Medical Vision — which has secured FDA


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clearances for algorithms meant to help identify collapsed lungs, brain bleeds, and early signs of coronary artery disease — is trying to develop algorithms for tuberculosis screening in rural parts of the country. To be sure, drug developers from all over the world have been running studies in India for years. But a recent confluence of factors has made India an increasingly popular research site for a new generation of companies working on biomedical AI tools. Smartphones and internet connections have proliferated in the world’s second most-populous country, offering a new way to collect valuable patient data. The costs of conducting research remain low, especially relative to wealthier countries. And for companies looking to develop a tool that can work anywhere, India offers a rich tapestry of linguistic and cultural variation. At the same time, conducting research in India intensifies many of the same challenges that make health tech hard enough in cutting-edge U.S. medical institutions. India has severe physician shortages. Much of its medical infrastructure is outdated. And in a system in which messy data are notorious for thwarting AI research in even the most futuristic hospitals in Silicon Valley and New York City, you can bet it’ll be even tougher in rural parts of India. STAT Health Tech by Rebecca Robins & Casey Ross; https://mailchi.mp/statnews/tk-593809?e=d897f06dcb

WOMEN IN SCIENCE & WOMEN’S HEALTH Is Sexual Desire A Medical Issue? An experimental drug meant to increase women’s drive for sex has raised questions over whether sexual desire should be a matter for pharmaceutical science. Via Stat.

Research On STEM Leadership & Lack Of Representation New AWIS research sheds light on lack of representation, especially by women of color, in STEM leadership positions. Organizational culture issues and recruitment gaps drive gender disparities in leadership positions, finds the newly released AWIS Transforming STEM Leadership Culture Report. Via AWIS.

Gender Stereotypes That Warp Biomedical Research

Longstanding gender stereotypes discouraged the use of female animals in biomedical research, to the detriment of women's health, and those stereotypes continue to introduce bias into study design and conclusions now that researchers are required to use female subjects, neuroscientist Rebecca Shansky writes in a perspective piece published in Science. Via The New York Times


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INDUSTRY RESOURCES & FUNDING OPPORTUNITIES Santé Ventures’ new $250M fund is looking for biotech upstarts Santé Ventures in Austin says it expects to make 20 to 25 new investments with this new fund, anywhere from seed to Series B. Learn more.

Apply For The CPRIT Product Development Program CPRIT announces the release of three Requests for Applications available to oncology-focused startup companies. Through Product Development grants, CPRIT invests in startup and early-stage companies in Texas (and those willing to relocate to Texas) to foster the development of novel cancer therapeutics, medical devices, diagnostics, tools, and other non-traditional oncology products. To date, CPRIT has awarded >$400 million to 34 startup and early-stage companies developing novel products to address unmet clinical needs in cancer. CPRIT’s Product Development Program offers three grant funding mechanisms:

1. SEED, for startups, up to $3 million 2. TXCO, for early-stage companies located in Texas, up to $20 million, 3. RELCO, for early-stage companies willing to relocate to Texas, up to $20 million.

Their next application cycle will begin on June 27, 2019 and awards will be announced in February 2020. For more information, please visit: cprit.texas.gov. Nominate an individual for the 2019 Dennis K. Stone Award The award will be given at the iC3 Conference on September 27th 2019. The Dennis K. Stone Award is presented annually by Bio North Texas to an individual who has positively affected quality of life by raising awareness and funds for life science research, who has impacted innovation to bring discoveries to commercial relevance, and who has given back to their community and those in the scientific field as a supporter, mentor, leader, or educator. Nominate a life science hero. Have an opportunity? Reach out to share it.


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Spotlight – MedtoMarket MedtoMarket is a 31,683 square-foot medical training and coworking facility located in the St. Elmo District in south central Austin. Founded by practicing physicians, MedtoMarket’s mission is to help medical innovators bridge the gap from concept to market. They help companies navigate the opaque and heavily regulated medical industry. Under one roof, MedtoMarket provides a one-stop shop for medical innovation with its two divisions: M2M Element Coworking and M2M Labs. From unique office space to multi-functional labs, along with direct access to physicians, MedtoMarket provides everything a medical startup company needs to bring their vision to life. Our co-founders are practicing doctors in the medical field. Therefore, startups receive “voice of the customer” feedback, real connections and resources.

“We provide frictionless movement for our startup companies and the physicians doing training and R&D in our facility. When you join MedtoMarket, all you have to do is show up ready to work.”

- Dr. Aaron Ali, MedtoMarket CEO and Co-Founder

Become a Member and Begin Building Your Team MedtoMarket’s coworking division, M2M Element, provides networking, mentorship and lab resources in the optimal environment to nurture a growing life sciences startup. When you have outgrown a single desk, upgrade to our larger offices. Big or small, they have the perfect home for your company. Once you have your team and business plan in place, utilize M2M Labs to test and refine your product. Reserve flex lab space, a mock operating room, or large skills labs. Research, refine and pivot where needed. Once your product or device is ready, showcase to investors, physicians, and life sciences companies in the Pitch Theater. Finally, shake hands with a key investor in the lobby bar after a networking event in the space. To learn more about MedtoMarket and explore the possibilities, check out www.medtomarket.com. To learn more about M2M Element’s full-service coworking space, startup mentorship, ample office spaces, and rich resource network, head to www.m2melementcoworking.com. To learn more about M2M Labs, one of the largest bioskills training and research facilities in the country, visit www.medtomarketlabs.com. MedtoMarket membership is currently open. Contact them today to schedule a tour of the new facility and secure your place before the rush! Those interested in coworking and/or lab space can apply at https://m2melement.officernd.com/signup.


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UPCOMING EVENTS You can see a compiled partner and community event calendar on the Capital City Innovation event web page. View Events JULY 2 | Dallas, TX | BioNTX Dallas Coffee Meetup Speaker Kellan Barfield, CEO Source Explorer, will be sharing the rapid growth this startup has made and how the company’s global search engine reduces the time to connect life science professionals with service suppliers. 7:30 AM - 9:00 AM. Sign up. JULY 16 | Austin, TX | UT Lunchtime Lecture Lunchtime Lectures is a new series of events intended to give alumni a taste of their college days. Lectures are $25 for members or $35 for nonmembers, and lunch is provided. July’s lecturer is Lucas Powe. He’s presenting America’s lone star constitution: how supreme court cases from Texas shape constitutional law. See all upcoming lunches and get your ticket JULY 17 | Webinar | FDA & NITRD Listening Session on Interoperability of Medical Devices The U.S. Food and Drug Administration (FDA) and The Networking and Information Technology Research and Development Program (NITRD) will host a listening session on the interoperability of medical devices, data and platforms. During the listening session, federal stakeholders will listen to the session participants explore solutions that promote a shared future vision of next generation, interoperable, and intelligent health systems. The feedback received from the listening session will provide potential research directions for advancing medical device interoperability. Meeting Details Location: The FDA’s White Oak Campus, Great Room - 10903 New Hampshire Avenue, Silver Spring, MD 20993 Registration Required, Webcast Available Time: 8:00 a.m. – 5:00 p.m. JULY 18 | Austin, TX | The importance of selecting the right Board and Advisors (TMDA Quarterly Meeting) 2-4pm at the Norris Conference Center. Get Your Ticket. RSVP to save your spot JULY 23 | Webinar | OR RESEARCH TEST DEVELOPMENT Multi-System Integration for Research Test Development… Free Webinar. After months or years in the research and development process, the time has come to build and test your widget. This often includes the integration of multiple complex mechanical, electrical, and software systems. In addition, the widget also has to be integrated into a testing interface to quantify the performance. The next step is the often underestimated effort known as “commissioning.” There are many challenges when incorporating a large number of subsystems. Software needs to control both the widget and the testing apparatus. Mechanical systems need to operate in unison. Subsystems need to be operated to improve the efficiency of the completed system. And problems that arise need to be identified and fixed through troubleshooting. This webinar investigates three case studies of the test development of prototype systems. The topics will include questions such as: How can safety be incorporated into


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the testing of new systems? How do you develop test procedures for the test subsystems? How can you be prepared when commissioning does not go as planned? How do you determine when the testing is complete? Join us to learn how to better prepare for the testing portion of your research and development.

Join the free webinar at 12:00 p.m. Central Time with host, Jordan Nielson To register, please email [email protected]. AUGUST 6 | Dallas, TX | BioNTX Dallas Coffee Meetup Speaker Kellan Barfield, CEO Source Explorer, will be sharing the rapid growth this startup has made and how the company’s global search engine reduces the time to connect life science professionals with service suppliers. 7:30 AM - 9:00 AM. Sign up. AUGUST 26 | Austin, TX | FMDIC FDA 101 This educational forum is intended for folks with little to no experience with FDA requirements for medical device manufacturers, specification developers, and initial distributors of imported devices. It is particularly useful to entrepreneurs, very small start-up companies, new hires, students planning a career in the medical device industry or enforcement, and administrative and marketing employees in medical device firms. Location/Time: M2M Element (2101 St. Elmo. Bldg. 1 Ste. 100, Austin, TX) from 8AM –5PM Price: $150.00 (refreshments and box lunch included) Registration Link: http://fmdic.org/events/ Contact: Jonnetta Wheaton, Communications Chair FDMIC, Inc., [email protected] OCTOBER 17 | Austin, TX | Clinical Research and CRO Experiences and Expectations (TMDA Quarterly Meeting) 2-4pm at the Norris Conference Center. Get Your Ticket. RSVP to save your spot OCTOBER 6–8 | Cleveland Downtown | Equity in STEM Community Convening The Equity in STEM Community Convening features 2.5 days of actionable and strategic content from researchers, practitioners and change agents who have innovated programs and interventions to share with the greater community. Learn more and Register July 25 | Austin, TX & live stream | Key Issues for Health Care Startups in Employment Law Compliance One of the biggest mistakes that startup founders make is not involving legal counsel early in the life of the business — including in the area of employment law compliance. Emphasizing the impact on health care startups, this presentation will provide an overview of such employment issues, including wage and hour compliance, classification of workers, the impact of restrictive covenants and more. Afterwards, join us for happy hour at Scholz Garten! Live streaming at Temple Health & Bioscience District, UTSA SBDC Technology Commercialization Center, and UT Health San Antonio. Register and learn more.


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CAREER CORNER

Abbott Clinical Research Scientist, Program Manager, Heart Failure, and multiple other positions. Visit jobs.abbott/us/en/search-results?keywords=austin Aeglea Biotherapeutics Process Engineer/Sr. Process Engineer, Sr. Clinical Project Manager, and multiple other positions. Visit aegleabio.com/biotechonology-careers/#career-opportunities ALKU – Texas Pharmaceutical QA Specialist, Epic ASAP Analyst, and Epic Grand central Prelude Analyst. Visit alku.com/ and contact Logan Blake, Regulatory & Scientific Recruiter at [email protected] Endocare, Inc. – Austin, Texas Position: Director, R&D and Engineering Description: Provides technical leadership and management oversight for R&D activities related to the development of cryo ablation and microwave ablation devices. Requirements: Degree in Electrical, Mechanical or related discipline (Masters & Ph.D. are preferred). A minimum of 15 years of related experience within the medical device industry. Experience managing teams where hardware, software, and disposables were part of product development. Knowledge in RF energy and cryotherapy systems. Contact: Audrey Coleman, HR Director ([email protected]) Remote P/T Regulatory Strategist (Dermatology) Alex Magoon |Recruiter – Life Sciences & Technology Black Diamond Networks 978.289.9741 [email protected]

Luminex (TX) Multiple Positions. Visit luminexcorp.com/about-luminex/careers/open-positions/ Molecular Templates (Austin, TX) Multiple positions. Visit mtem.com/careers/ Syneos Health Multiple positions. Visit syneoshealth.com/careers Theradiag Head of Business-US. Visit www.theradiag.com REMOTE Medical Writing consulting opportunities Michelle Cloutier | Regulatory & Scientific Recruiter ALKU 978.296.6934 [email protected] Asuragen Senior Scientist: Research, Bioinformatics, Production Scientist, and multiple other positions. Visit asuragen.com/careers/ FDA Quality and Regulatory Consultants (FDAQRC) FDA Quality and Regulatory Consultants LLC offers specialized Quality and Regulatory Consulting for Pharmaceutical, Medical Device and Biotech companies. Due to our Food and Drug Administration experiences, we provide customized, value-added solutions, processes and enhanced quality standards to optimize business. Visit fdaqrc.com/careers/ Theradiag Head of Business-US – Richmond, VA Capitalizing on its expertise in the development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of chronic


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Sr. Director/Director, Regulatory Affairs (Orange County, California) Are you interested in working for an organization that is making a difference in people’s lives every day? I am working with a medical device company that develops innovative neuroendovascular technologies for the treatment of vascular disease. The company is high-growth, customer-focused and has an entrepreneurial spirit. This company engages in the development of catheter-based, minimally invasive, neuro-endovascular technologies for therapeutic advantages for cerebral aneurysms and other neurovascular diseases. Products include WEB Aneurysm Embolization System used for the treatment of intracranial neck bifurcation aneurysms; and delivery and detachment systems, access products, intraluminal devices, occlusion balloons, and flow diverters, as well as polymer, platinum, and hydrogel coil products. It markets its products through a network of specialty distributors primarily in North America, South America, Europe, Africa, the Middle East, and the Asia Pacific. Contact: Andrew Brown, Medical Device Search Group, Inc., (786)372-4343, [email protected], medicaldevicesearchgroup.com Paratus Diagnostics Paratus Diagnostics is always looking for exceptional talent to join our growing team. Conveniently located in San Marcos, we are right in the middle of the rapidly growing Austin to San Antonio technology corridor. With about 5,000 square feet of laboratory and office space, we research, develop, manufacture, and test the Paratus PreparedNow® System right in the heart of Texas. Full listing of multiple Paratus open positions at paratusdiagnostics.com/careers. Interested candidates should apply directly to Paratus CEO Dr. John C. Carrano at [email protected] Skills Alliance, Market Access and Contracting

inflammatory diseases and cancer. Theradiag is thus participating in personalized medicine, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. The Company is based in Marne-la- Vallée, near Paris, and has over 60 employees motivated and passionate about making it their mission to help improve patient’s care through innovation. For more information about Theradiag, please visit our website: www.theradiag.com They currently have an exceptional opportunity for a Head of Business for the US Territory. You will be responsible for driving company’s business growth in the USA. This shall be accomplished by commercial offer of Theradiag OptimAbs testing services resulting in an increase of number of tests ordered by physicians. Your role is to commercialize the value proposition of OptimAbs testing, initiate partnership with the pharmaceutical industry and educate clinical centres, practices on benefits of OptimAbs tests. In order to achieve these goals, you will be supported by company’s management, marketing, reimbursement and technical departments. Ideally the person will be based close to or in Richmond, VA. You will report to the Theradiag’s business Unit Director – Theranostics. For more information or to apply, send an email to [email protected] with the subject line: “Sales manager / Therapeutic Drug Monitoring” VP Operations, Paradromics Paradromics is bringing to market the first high-bandwidth data interface between brains and computers. Paradromics is looking for a Vice President of Operations, reporting directly to the CEO. The candidate will be responsible for managing the essential operational functions of a medical device company: Quality Assurance, FDA Regulatory


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Professional Skills Alliance, a global life sciences recruitment agency specializing in placements across the Pharma, Biotech and Medical Device Industries has a great opportunity for a Market Access and Contracting professional specializing in US managed markets. This position will be with a prominent Market Access consultancy in NY and will be reporting to the Head of US Market Access. You must have at least a Bachelors’ degree, Market Access/Managed Markets experience, consulting experience, at least 5 years of payer and reimbursement formulated strategy experience, and previous project management experience. Send inquiries and resume to [email protected] QA Consulting, Inc Job Titles: Quality Engineering Consultant and Senior Quality Engineering Consultant (2 separate jobs), Software Quality Engineer (contract position) Website: www.qaconsultinginc.com Contact Info: Mallori Groh at [email protected]

Compliance, Manufacturing, Project Management, Facilities, and Logistics. This will involve hiring and leading a team of specialists and managers to oversee these functions. The ideal candidate will have some experience in most or all of these areas but is not expected to be a specialist in all areas. Emphasis will be placed upon medical device manufacturing experience, with a preference for manufacturing of implantable electronic devices. Contact Chelsea Coleman for more details and to apply at [email protected]


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Looking for Opportunities Jack Zamen: Biomedical Engineer Intern I am a freshman engineering student at Texas A&M University. Next year I will be majoring in biomedical engineering. I am looking for an internship this summer at a medical device company in Austin. I am disciplined, a hard worker, take direction well and a team player. I can provide my resume for review. Additionally, if you happen to know anyone looking for summer help or could point me in the right direction, I would really appreciate it. Please contact me at: Jack Zamen, [email protected] | 512-800-5852. Stephanie Cohen: Bioengineer I am looking for an entry-level engineering role. I have a bachelor's degree in Engineering Physics (specialized in Bioengineering) and Physics. My experience with medical devices includes systems engineering, quality assurance, and inspection/repair. I have optics and optical design experience. I also have experience with quality assurance and testing of software, both manual and automated, some programming experience with Python, C++, and javascript/Groovy. I'm bilingual in English and Spanish. I am seeking employment in Austin and the surrounding area, and I'm also willing to relocate and open to remote work as well. Contact me at [email protected]. LinkedIn: linkedin.com/stephanie-cohen Well-Qualified Interns From ACC Biotechnology Program Looking For Positions! Contact Dr. Linnea Fletcher, Department Chair ([email protected] or call 512 -223-5912), or Steven Spurlock ([email protected] or call 512 223-5915), Administrative Assistant for more information. For more information about the program visit Austin Community College Biotechnology Program at sites.austincc.edu/biotech


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TEXAS LIFE SCIENCE ORGANIZATIONS ATX Women in MedTech [email protected] Austin Health Tech Meetup meetup.com/Austin-Health-Tech/ Austin Technology Incubator (ATI) ati.utexas.edu BioAustin LinkedIn Group Linkedin.com/groups/6535301/profile BioHouston biohouston.org/ BioMed San Antonio biomedsa.org BioNorth bionorthtx.org/ Capital City Innovation capitalcityinnovation.org/ Health Technology Forum Meetup meetup.com/HealthTechnologyForum-Austin/ Health Wildcatters, Dallas healthwildcatters.com

Temple Health & Bioscience District templebioscience.com/ Texas Biomedical Research Institute, San Antonio txbiomed.org/ TX Health Catalyst, Austin dellmed.utexas.edu/thc Texas Medical Device Alliance (TMDA) LinkedIn Group linkedin.com/groups/6952028 The Health Cell, San Antonio thehealthcell.org TMCX/TMCX+, Houston mc.edu/innovation/innovation-programs/tmcx-plus/ Top Austin-Area Medical Device Companies https://tinyurl.com/ya9v2s5u Velocity Texas, San Antonio velocitytx.org/ Women in Bio-Texas (WIB-TX, Austin & Houston) womeninbio.org/page/texas

Know of another organization? Reach out to share it.


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VOLUNTEER OPPORTUNITIES

Join the BioAustin/TMDA/AHT Newsletter Team! Content is provided (but we welcome new sources and original content too), and the work of compiling, editing and web publishing is shared. Contact Elisa Maldonado-Holmertz at [email protected] to learn more.

BioAustin/ TMDA/ AHT/ TX Health Catalyst/Capital Factory/Capital City Innovation/ Health Tech Austin We are interested in mapping the Austin’s landscape in healthcare/life sciences/biotech/medtech. Anyone interested in volunteering to collect/compile this information as a team? If you are, please contact Scott Collins at [email protected]. ATX Women in MedTech Looking for volunteers to support community outreach, event management, PR, sponsorship and more. Email [email protected] for details. BioAustin We are seeking volunteers to maintain our website. If interested, please reach out to Scott Collins at [email protected]

THANKS TO OUR TMDA SPONSORS! With warm regards, Dana Abramovitz, Elisa Maldonado-Holmertz, Victoria O’Dell and Tamiko Oguri on behalf of BioAustin, Texas Medical Device Alliance (TMDA), Austin HealthTech (AHT), and Capital City Innovation (CCI).

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